User Evaluation of the MiniMed 640G Insulin Pump

A User Evaluation of the MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

This four center international study will include two United Kingdom National Health Service centers, and two centers in Melbourne, Australia. The objective of the study is to evaluate subject acceptance of a new insulin pump and transmitter together with the accompanying training materials. Descriptive data from participant questionnaires and device uploads will be evaluated.

Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of age upwards, who currently use an insulin pump in the management of their type 1 or type 2 diabetes, will be invited to participate. Each subject will be trained on the study device and then use it for approximately four weeks. During this time there will be three in-clinic visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of this period, they will revert back to their original insulin pump and complete a questionnaire on the study pump training materials, features and usability.

Criteria for Inclusion: A subject is eligible for the user evaluation study if all of the following criteria are met:

1. Subject is 7 years or older at time of screening

2. Subject is current insulin pump user for at least 3 months

3. Subject has the following CGM experience as determined by the Investigator:

   • Has experience and is able to insert/change sensor by herself/himself and
   • Has experience and can recharge the transmitter and
   • Has experience and can read sensor data in real-time on her/his pump screen

4. Subject/legal representative has signed a Patient Informed Consent and is willing to comply with the study procedures;

5. Subject is willing to complete study questionnaires throughout the study

6. Must have the following clinical diagnosis:

1. Type 1 diabetes, for a minimum of 6 months prior to enrollment

Criteria for Exclusion: A subject is excluded from the user evaluation if any of the following criteria are met:

1. Female subject has a positive urine pregnancy screening test.
2. Female subject who plans to become pregnant during the course of study. If a woman becomes pregnant during participation, she will be withdrawn
3. Subject has any condition that, in the opinion of the Investigator or qualified Investigational Centre staff, may preclude him/her from participating in the study and completing study related procedures.
4. Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Centre staff
5. Subject is unable to tolerate tape adhesive in the area of sensor placement
6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection)
7. Subject has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled
8. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks (CEP267 User Evaluation is not included in this exclusion criteria).